Senior Associate Manufacturing - Electronic Batch Record Support (Multiple Positions)
Amgen
Summary
Support the start-up of the Amgen North Carolina (ANC) manufacturing facility as a manufacturing support role responsible for the generation of electronic documentation, tracking of EBR metrics, and communication between operations teams and functional groups.
Job description
Job Scope and Responsibilities
- Manufacturing support focused on Electronic Batch Record (EBR) generation using PAS-X (Korber), editing, real-time troubleshooting and managing the EBR validation for new or modified processes.
- Assist in the implementation of new MES integrations and functionalities.
- Support manufacturing in the troubleshooting and execution of EBRs.
- Create and maintain Electronic Batch Records.
- Support optimization of EBRs to improve functionality and align with process requirements.
- Contribute to Lean Transformation through recording EBR metrics and application of continuous improvement tools.
- Participate and contribute to projects to introduce new products and/or advancement of new manufacturing technologies into the plant.
Basic Qualifications
- High School/GED and 4 years of manufacturing or operations work experience OR
- Associate’s Degree and 2 years of manufacturing or operations work experience OR
- Bachelor’s Degree and 6 months of manufacturing or operations work experience OR
- Master’s Degree
Preferred Qualifications
- Completion of NC BioWorks Certification Program.
- Experience in biotechnology or pharmaceutical plant start up.
- Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment.
- Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation.
- Excellent verbal and written communication (technical) skills.
- Proficient Microsoft Office skills, and knowledge of other electronic systems such as SAP, EBR/MES, Delta V, and Electronic Quality Systems.
- Experience with PAS X (Korber) or comparable software for electronic batch records with some understanding of editing and validation.
Requirements
- High School/GED and 4 years of manufacturing or operations work experience OR Associate’s Degree and 2 years of manufacturing or operations work experience OR Bachelor’s Degree and 6 months of manufacturing or operations work experience OR Master’s Degree
- Completion of NC BioWorks Certification Program
- Experience in biotechnology or pharmaceutical plant start up
- Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
- Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation
- Excellent verbal and written communication (technical) skills
- Proficient Microsoft Office skills, and knowledge of other electronic systems such as SAP, EBR/MES, Delta V, and Electronic Quality Systems
- Experience with PAS X (Korber) or comparable software for electronic batch records with some understanding of editing and validation
Benefits
- Health insurance
- Dental coverage
- Vision coverage
- Retirement and savings plan
- Life insurance
- Disability insurance
- Flexible spending accounts
- Annual bonus program
- Stock-based long-term incentives
- Paid time off
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.